Table 1. Major studies for different types of LAAO devices: Watchman.
| PROTECT AF†10) | PREVAIL†11) | CAP registry13) | CAP 2 registry12),14) | EWOLUTION15) | UK registry16) | |
|---|---|---|---|---|---|---|
| Study types | Randomized trial | Randomized trial | Prospective registry | Prospective registry | Prospective registry | Retrospective |
| Population | 463/244 | 269/138 | 460 | 579 | 1,021 | 371 (watchman=234, ACP=129, Lariat=6, Coherex Wavecrest =2) |
| Implantation success rate (%) | 91 | 95.1 | 95 | 94.8 | 98.5 | 92.5 |
| CHA2DS2-Vasc | ≥1* | Mean 3.8* | Mean 2.4 | 2.7 | 4.5 | 4.2 |
| HAS-BLED score | ≥1 in 97% | 2.3 | 3.3 | |||
| Anticoagulation used | Warfarin for 45 days post implantation followed by aspirin and Plavix × 6 months then aspirin alone | Warfarin for 45 days post implantation followed by aspirin and Plavix × 6 months then aspirin alone | Warfarin for 45 days post implantation followed by aspirin and Plavix × 6 months then aspirin alone | Warfarin for 45 days post implantation followed by aspirin and Plavix × 6 months then aspirin alone | 27% treated with OAC, 59% on dual antiplatelets, 7% single APT, 6% without any therapy | OAC-20%, DAPT 50%, OAC plus single APT-20%, single APT-10% |
| Ischemic stroke (%) | 2.2/1.6 | 1.9/0.7 | - | - | - | 0.1 |
| Hemorrhagic stroke (%) | 0.1/1.6 | 0.4/0 | - | - | - | 0.5 |
| Major bleeding (%) | 3.5/4.1 | 0.4/NA | 0.7 | - | 0.7 | 0.5 |
| Pericardial effusion/tamponade (%) | 4.8/0 | 0.4/0 | 2.2 | 2.4 | 0.5 | 0.8 |
| Device embolization (%) | 0.6/0 | 0.7/0 | 0 | 0 | 0.2 | 1.3 |
| Procedure-related stroke (%) | 1/0 | 0.4/0 | 0 | - | - | - |
ACP = Amplatzer Cardiac Plug; APT = antiplatelet therapy; DAPT = dual antiplatelet therapy; LAAO = left atrial appendage occlusion; NA = not available; OAC = oral anticoagulation.
*CHADS2; †Randomized studies, n/n=LAAO/warfarin arms.